Trial Outcomes & Findings for GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men. (NCT NCT00381303)
NCT ID: NCT00381303
Last Updated: 2014-04-21
Results Overview
TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
429 participants
Primary outcome timeframe
Week 48
Results posted on
2014-04-21
Participant Flow
Participant milestones
| Measure |
Female
darunavir 600 milligram (mg) twice daily dosing (bid) for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
darunavir 600 mg twice bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
287
|
142
|
|
Overall Study
COMPLETED
|
193
|
109
|
|
Overall Study
NOT COMPLETED
|
94
|
33
|
Reasons for withdrawal
| Measure |
Female
darunavir 600 milligram (mg) twice daily dosing (bid) for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
darunavir 600 mg twice bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
25
|
9
|
|
Overall Study
AE/HIV-related event
|
22
|
6
|
|
Overall Study
Non-Adherence
|
13
|
6
|
|
Overall Study
Withdrawal by Subject
|
13
|
6
|
|
Overall Study
Virologic failure
|
6
|
4
|
|
Overall Study
Ineligible to continue the trial
|
2
|
1
|
|
Overall Study
Pregnancy
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Physician's decision to close the site
|
3
|
1
|
|
Overall Study
Subject moved out of state
|
2
|
0
|
|
Overall Study
Subject taking too many different meds
|
1
|
0
|
|
Overall Study
No virologic response by week 12
|
1
|
0
|
|
Overall Study
Subject was too busy for appointments
|
1
|
0
|
|
Overall Study
Subject did not continue visits
|
1
|
0
|
|
Overall Study
Subject primary physician's decision
|
1
|
0
|
Baseline Characteristics
GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.
Baseline characteristics by cohort
| Measure |
Female
n=287 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=142 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Total
n=429 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
n=99 Participants
|
45 years
n=107 Participants
|
43 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
287 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
287 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
191 participants
n=99 Participants
|
73 participants
n=107 Participants
|
264 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
34 participants
n=99 Participants
|
31 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
60 participants
n=99 Participants
|
36 participants
n=107 Participants
|
96 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Previous Antiretroviral (ARV) Experience: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
NNRTI: < 1 drug count
|
83 participants
n=99 Participants
|
32 participants
n=107 Participants
|
115 participants
n=206 Participants
|
|
Previous Antiretroviral (ARV) Experience: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
NNRTI: >= 1 drug count
|
204 participants
n=99 Participants
|
110 participants
n=107 Participants
|
314 participants
n=206 Participants
|
|
Previous ARV experience: Protease inhibitor (PI)
PI: <2
|
119 participants
n=99 Participants
|
50 participants
n=107 Participants
|
169 participants
n=206 Participants
|
|
Previous ARV experience: Protease inhibitor (PI)
PI: >=2
|
168 participants
n=99 Participants
|
92 participants
n=107 Participants
|
260 participants
n=206 Participants
|
|
CD4+ cell count
|
210 cells/L
n=99 Participants
|
175 cells/L
n=107 Participants
|
200 cells/L
n=206 Participants
|
|
Plasma log10 copies/mL VL HIV-1 RNA
|
4.65 copies/mL
STANDARD_DEVIATION 0.883 • n=99 Participants
|
4.73 copies/mL
STANDARD_DEVIATION 0.856 • n=107 Participants
|
4.67 copies/mL
STANDARD_DEVIATION 0.874 • n=206 Participants
|
|
Time since HIV-infection diagnosis
|
10.78 years
n=99 Participants
|
11.91 years
n=107 Participants
|
11.3 years
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Intention to Treat (ITT)
TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability
Outcome measures
| Measure |
Female
n=287 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=142 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Hispanic
|
Asian
|
Other
|
Asian
|
Other
|
|---|---|---|---|---|---|---|---|
|
Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex
|
146 participants
|
83 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 48Population: TLOVR non-virologic failure (VF) censored
TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.
Outcome measures
| Measure |
Female
n=200 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=113 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Hispanic
|
Asian
|
Other
|
Asian
|
Other
|
|---|---|---|---|---|---|---|---|
|
Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex
|
146 participants
|
83 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: ITT
Intention to Treat population (ITT)
Outcome measures
| Measure |
Female
n=264 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=65 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Hispanic
n=96 Participants
|
Asian
n=2 Participants
|
Other
n=2 Participants
|
Asian
|
Other
|
|---|---|---|---|---|---|---|---|
|
Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race
|
128 participants
|
39 participants
|
59 participants
|
2 participants
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: ETR Subgroup- Intention to Treat population (ITT)
The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)
Outcome measures
| Measure |
Female
n=119 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=88 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Hispanic
n=133 Participants
|
Asian
n=34 Participants
|
Other
n=36 Participants
|
Asian
n=2 Participants
|
Other
n=2 Participants
|
|---|---|---|---|---|---|---|---|
|
Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects
|
69 participants
0.088
|
54 participants
0.131
|
74 participants
0.092
|
21 participants
0.191
|
25 participants
0.158
|
2 participants
0.472
|
1 participants
-1.73
|
SECONDARY outcome
Timeframe: Week 48Population: TLOVR Non-virologic Failure(VF) Censored
TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.
Outcome measures
| Measure |
Female
n=186 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=50 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Hispanic
n=74 Participants
|
Asian
n=2 Participants
|
Other
n=1 Participants
|
Asian
|
Other
|
|---|---|---|---|---|---|---|---|
|
Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race
|
128 participants
|
39 participants
|
59 participants
|
2 participants
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Etravirine-TMC125 (ETR) Subgroup \[TLOVR Non-virologic Failure (VF) Censored\]
The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR) TLOVR non-virologic failure(VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.
Outcome measures
| Measure |
Female
n=87 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=74 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Hispanic
n=102 Participants
|
Asian
n=26 Participants
|
Other
n=30 Participants
|
Asian
n=2 Participants
|
Other
n=1 Participants
|
|---|---|---|---|---|---|---|---|
|
Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA
|
69 participants
|
54 participants
|
74 participants
|
21 participants
|
25 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: ITT
Observed obsevations have no imputation methods applied.
Outcome measures
| Measure |
Female
n=188 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=105 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Hispanic
n=173 Participants
|
Asian
n=47 Participants
|
Other
n=70 Participants
|
Asian
n=2 Participants
|
Other
n=1 Participants
|
|---|---|---|---|---|---|---|---|
|
Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values
|
152 x10^6 cells/L
Standard Error 11.2
|
122 x10^6 cells/L
Standard Error 12.3
|
143 x10^6 cells/L
Standard Error 10.8
|
151 x10^6 cells/L
Standard Error 23.8
|
133 x10^6 cells/L
Standard Error 17.0
|
45 x10^6 cells/L
Standard Error 24.5
|
179 x10^6 cells/L
|
SECONDARY outcome
Timeframe: Week 48Population: Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)
The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)
Outcome measures
| Measure |
Female
n=80 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=67 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Hispanic
n=93 Participants
|
Asian
n=25 Participants
|
Other
n=26 Participants
|
Asian
n=2 Participants
|
Other
n=1 Participants
|
|---|---|---|---|---|---|---|---|
|
Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values
|
136 x10^6 cells/L
Standard Error 15.8
|
108 x10^6 cells/L
Standard Error 15.1
|
135 x10^6 cells/L
Standard Error 13.5
|
111 x10^6 cells/L
Standard Error 26.7
|
98 x10^6 cells/L
Standard Error 29.8
|
45 x10^6 cells/L
Standard Error 24.5
|
179 x10^6 cells/L
|
SECONDARY outcome
Timeframe: Week 48Population: ITT LOCF
Last Observation Carried Forward (LOCF) imputation method applied.
Outcome measures
| Measure |
Female
n=287 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=142 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Hispanic
n=264 Participants
|
Asian
n=65 Participants
|
Other
n=96 Participants
|
Asian
n=2 Participants
|
Other
n=2 Participants
|
|---|---|---|---|---|---|---|---|
|
Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)
|
112 x10^6 cells/L
Standard Error 8.8
|
103 x10^6 cells/L
Standard Error 11.2
|
109 x10^6 cells/L
Standard Error 8.9
|
110 x10^6 cells/L
Standard Error 20.4
|
109 x10^6 cells/L
Standard Error 13.5
|
45 x10^6 cells/L
Standard Error 24.5
|
138 x10^6 cells/L
Standard Error 41.0
|
SECONDARY outcome
Timeframe: Week 48Population: Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)
The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR). The Last Observation Carried Forward (LOCF) imputation method was applied.
Outcome measures
| Measure |
Female
n=119 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=88 Participants
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Hispanic
n=133 Participants
|
Asian
n=34 Participants
|
Other
n=36 Participants
|
Asian
n=2 Participants
|
Other
n=2 Participants
|
|---|---|---|---|---|---|---|---|
|
Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF
|
107 x10^6 Cells/L
Standard Error 12.7
|
98 x10^6 Cells/L
Standard Error 14.0
|
113 x10^6 Cells/L
Standard Error 12.1
|
84 x10^6 Cells/L
Standard Error 21.7
|
90 x10^6 Cells/L
Standard Error 22.6
|
45 x10^6 Cells/L
Standard Error 24.5
|
138 x10^6 Cells/L
Standard Error 41.0
|
Adverse Events
Female
Serious events: 47 serious events
Other events: 73 other events
Deaths: 0 deaths
Male
Serious events: 33 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Female
n=287 participants at risk
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=142 participants at risk
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Cardiac disorders
Angina Pectoris
|
0.70%
2/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Cardiac disorders
Cardiac Failures Congestive
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Cardiac disorders
Cardiac Tamponade
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Cardiac disorders
Myocardial Infarction
|
0.70%
2/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Gastrointestinal disorders
Acquired Oesophageal Web
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Gastrointestinal disorders
Gatrointestinal Haemorrhage
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Gastrointestinal disorders
Oesophageal Ulcer
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Gastrointestinal disorders
Oesophagitis
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
General disorders
Chest Pain
|
0.00%
0/287 • 48 Weeks
|
2.8%
4/142 • 48 Weeks
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
0.70%
2/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Hepatobiliary disorders
Hepatitis
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Immune system disorders
Drug Hypersensitivity
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Immune system disorders
Hypersensitivity
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Abscess
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Abcess Limb
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Bacterial Pyelonephritis
|
0.70%
2/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Infections and infestations
Bacterial Sepsis
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Bartonellosis
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Cellulitis
|
0.70%
2/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Cytomegalovirus Oesophagitis
|
0.00%
0/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Gastroenteritis
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Gastroenteriris Cryptosporidial
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Gonorrhoea
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Herpes Zoster Ophthalmic
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Lung Infection Pseudomonal
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Meningitis Aseptic
|
0.00%
0/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Meningitis Tuberculous
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Meningitis Viral
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Pneumocystis Jiroveci Pneumonia
|
0.35%
1/287 • 48 Weeks
|
2.8%
4/142 • 48 Weeks
|
|
Infections and infestations
Pneumonia
|
3.5%
10/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Pneumonia Legionella
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Rectal Abcess
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Septic Arthritis Staphylococcal
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Sinusitus
|
0.00%
0/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Staphylococcal Abcess
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Staphylococcal Infection
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Infections and infestations
Toxoplasmosis
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.70%
2/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.70%
2/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Viral Infection
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Infections and infestations
Accidental Overdose
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Investigations
Alanine Amino Transferase Increased
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Investigations
Aspartate Amino Transferase Increased
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Investigations
Blood Amylase Increased
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Investigations
Blood Lactic Acid Increased
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Investigations
Transaminases Increased
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal Cancer Stage 0
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval Cancer
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Nervous system disorders
Convulsion
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Nervous system disorders
Headache
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Nervous system disorders
Status Epilepticus
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Pregnancy, puerperium and perinatal conditions
Pre-Eclampsia
|
0.00%
0/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Pregnancy, puerperium and perinatal conditions
Premature Labour
|
0.00%
0/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Psychiatric disorders
Alcoholism
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Psychiatric disorders
Catatonia
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Psychiatric disorders
Conversion Disorder
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Psychiatric disorders
Delirium
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Psychiatric disorders
Dependence
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Psychiatric disorders
Depression
|
0.70%
2/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Psychiatric disorders
Major Depression
|
0.35%
1/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Psychiatric disorders
Suicide Attempt
|
0.70%
2/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.70%
2/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.70%
2/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.70%
2/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Angioneurotic Oedema
|
0.70%
2/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.35%
1/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Social circumstances
Drug Abuser
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/287 • 48 Weeks
|
1.4%
2/142 • 48 Weeks
|
|
Vascular disorders
Haemorrhage
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Vascular disorders
Thrombosis
|
0.35%
1/287 • 48 Weeks
|
0.00%
0/142 • 48 Weeks
|
|
Vascular disorders
Vascular Insufficiency
|
0.00%
0/287 • 48 Weeks
|
0.70%
1/142 • 48 Weeks
|
Other adverse events
| Measure |
Female
n=287 participants at risk
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
Male
n=142 participants at risk
darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.0%
20/287 • 48 Weeks
|
5.6%
8/142 • 48 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
16.4%
47/287 • 48 Weeks
|
21.8%
31/142 • 48 Weeks
|
|
Gastrointestinal disorders
Nausea
|
24.4%
70/287 • 48 Weeks
|
14.1%
20/142 • 48 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
33/287 • 48 Weeks
|
6.3%
9/142 • 48 Weeks
|
|
General disorders
Oedema Peripheral
|
5.6%
16/287 • 48 Weeks
|
4.2%
6/142 • 48 Weeks
|
|
General disorders
Pyrexia
|
4.9%
14/287 • 48 Weeks
|
8.5%
12/142 • 48 Weeks
|
|
Infections and infestations
Bronchitis
|
6.3%
18/287 • 48 Weeks
|
4.9%
7/142 • 48 Weeks
|
|
Infections and infestations
Oral Candidiasis
|
6.6%
19/287 • 48 Weeks
|
4.9%
7/142 • 48 Weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.5%
30/287 • 48 Weeks
|
7.7%
11/142 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.6%
19/287 • 48 Weeks
|
4.9%
7/142 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.6%
16/287 • 48 Weeks
|
7.7%
11/142 • 48 Weeks
|
|
Nervous system disorders
Headache
|
9.1%
26/287 • 48 Weeks
|
7.7%
11/142 • 48 Weeks
|
|
Psychiatric disorders
Depression
|
5.2%
15/287 • 48 Weeks
|
7.0%
10/142 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
27/287 • 48 Weeks
|
8.5%
12/142 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.6%
19/287 • 48 Weeks
|
3.5%
5/142 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
23/287 • 48 Weeks
|
7.7%
11/142 • 48 Weeks
|
Additional Information
Vice President, Tibotec Therapeutics Clinical Affairs
Tibotec Therapeutics Clinical Affairs (TTCA), Division of Centocor Ortho Biotech Services, LLC
Phone: 877-732-2488
Results disclosure agreements
- Principal investigator is a sponsor employee If TTCA does not publish within 12 months after study conclusion or after TTCA confirms there will be no multicenter publication, Institution may publish their results from their site individually, provided TTCA has 60 day review for confidentiality and additional 60 day delay for patent application.
- Publication restrictions are in place
Restriction type: OTHER